What Is Glatiramer Acetate?
Glatiramer Acetate is a prescription medication that can be injected subcutaneously to treat relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Every dose of Glatiramer Acetate is composed of a complex mixture of polypeptides containing four naturally occurring amino acids:
Some scientists think that MS may result when the body’s immune system attacks the myelin sheath that surrounds and protects nerve cell axons.1 Although the mechanism of action of Glatiramer Acetate is not fully known, there is evidence that it may help reduce MS relapses by interrupting this immune system attack.1
What Is Mylan’s Glatiramer Acetate Injection?
Glatiramer Acetate Injection from Mylan is an FDA-approved therapeutic equivalent to Copaxone® (glatiramer acetate injection), available in two doses
A Complex Drug, But Not a Biologic
You may have seen Mylan’s Glatiramer Acetate Injection incorrectly referred to as a biologic in articles, conference presentations or posts on the web.
According to the FDA, a biologic is a protein derived from living material used to treat or cure disease. Because the polypeptides that make up Glatiramer Acetate are manufactured in the lab, it is not classified as a biologic.4
GLATIRAMER ACETATE INJECTION is a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
IMPORTANT SAFETY INFORMATION
Do not take GLATIRAMER ACETATE INJECTION if you are allergic to glatiramer acetate or mannitol.
Serious side effects may happen right after or within minutes after you inject glatiramer acetate injection at any time during your course of treatment. Call your doctor right away if you have any of these immediate post-injection reaction symptoms including: redness to your cheeks or other parts of the body (flushing); chest pain; fast heart beat; anxiety; breathing problems or tightness in your throat; or swelling, rash, hives, or itching. If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a doctor tells you to.
Chest pain may occur either as part of the immediate post-injection reaction or on its own. This pain usually only lasts a few minutes or can begin around 1 month after you start using glatiramer acetate injection. Call your doctor right away if you experience chest pain.
A permanent indentation under the skin (lipoatrophy and, rarely, death of your skin tissue also referred to as necrosis) at the injection site may occur due to local destruction of fat tissue. In order to reduce your chance of developing these problems, be sure to follow your doctor's instruction on how to use glatiramer acetate injection and be sure to choose a different injection site each time you use glatiramer acetate injection.
Liver problems, including liver failure, can occur with GLATIRAMER ACETATE INJECTION. Call your healthcare provider right away if you have symptoms, such as nausea, loss of appetite, tiredness, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal, confusion, or sleepiness.
The most common side effects in studies of GLATIRAMER ACETATE INJECTION are redness, pain, swelling, itching, or a lump at the site of injection, rash, shortness of breath, and flushing. These are not all the possible side effects of GLATIRAMER ACETATE INJECTION. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects that you have while taking GLATIRAMER ACETATE INJECTION.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.